BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 22888318 · Received August 25, 2025

    Report

    Report Number
    1320894-2025-00208
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    July 25, 2025
    Report Date
    September 26, 2025
    Manufacturer
    CONMED UTICA
    Product Code
    HFG
    PMA / PMN Number
    K904240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT OF ¿TIP MELTED¿ IS CONFIRMED. THE REPORTED EVENT THAT THE PLASTIC PART OF THE L-HOOK MELTED OFF WAS CONFIRMED. EXAMINATION OF RETURNED USED 60-5163-001 DEVICE FOUND THAT THE BLACK MATERIAL COVERING THE TIP OF THE ELECTRODE HAD MELTED AWAY AND THE ENDS WERE LEFT FRAYED. ROOT CAUSE CANNOT BE DETERMINED, HOWEVER, BASED UPON THE IFU; A POSSIBLE CAUSE OF THIS EVENT COULD BE THAT THE ELECTRODE INSULATION IS CRACKED, OR DAMAGED. A TWO-YEAR LOT HISTORY REVIEW SHOWS A TOTAL OF 3 DEVICES FOR THIS LOT NUMBER AND FAILURE MODE. A DEVICE HISTORY RECORD (DHR) REVIEW FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS REPORTED EVENT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 8 COMPLAINTS, REGARDING 8 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO INSPECT THE INSULATION ON THE INSTRUMENT SHAFT. DO NOT USE AN INSTRUMENT OR ELECTRODE IF THE INSULATION IS CRACKED, OR DAMAGED. THIS PRODUCT IS DESIGNED FOR NON-CONTINUOUS OPERATION, WITH A DUTY CYCLE OF 10 SECONDS ON, AND 30 SECONDS OFF. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-5163-001 LAPAROSCOPIC ELECTRODE WITH A 3/32" PIN CONNECTOR,L-HOOK DEVICE WAS BEING USED DURING A LAP CASE PROCEDURE ON 25JUL25 WHEN IT WAS REPORTED ¿L-HOOK INSULATED TIP MELTED INSIDE PATIENT DURING SURGERY.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS RETRIEVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-5163-001 LAPAROSCOPIC ELECTRODE WITH A 3/32" PIN CONNECTOR, L-HOOK DEVICE WAS BEING USED DURING A LAP CASE PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿L-HOOK INSULATED TIP MELTED INSIDE PATIENT DURING SURGERY.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS RETRIEVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616980 CONMED COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) HFG CONMED UTICA 202404011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown